Valve for exchange transfusion system



Oct.'3, 1967 D. A HAMILTON 3,344,785

VALVE FOR EXCHANGE TRANSFUSION SYSTEM Filed Feb. 1, 1965 2 Sheets-Sheet 1 wvav r09 00/641 0 A. l/A/I/l f0! Oct. 3, 1967 D. A. HAMILTON VALVE FOR EXCHANGE TRANSFUSION SYSTEM 2 Sheets-Sheet 2 Filed Feb. 1, 1965 l/Vl/EN TOR DUI/1410 A. l/Ml/Z 70/! United States Patent 3,344,785 VALVE FOR EXCHANGE TRANSFUSION SYSTEM Donald A. Hamilton, Burbank, Calif., assiguor to Pharmaseal Laboratories, Glendale, Calif., a corporation of California Filed Feb. 1, 1965, Ser. No. 429,410 7 Claims. (Cl. 128214) ABSTRACT OF THE DISCLOSURE A disposable molded valve for exchange transfusing used, for example, to remove and replace the blood of newborn infants, in which a ported core is rotatably secured in a valve body by a puncturable, resealable diaphragm assembly at one end and is connectable to a syringe at the other end, and the valve body includes a plurality of radially spaced, tubular side arms selectively communicatable with the core port during transfusion procedures and medicants and/or solvents can be introduced through the diaphragm assembly.

An exchange transfusion is a procedure used to treat newborn infants when an Rh factor or blood group incompatibility exists. This procedure includes replacing a major portion of the infants blood with new compatible blood. In the procedure, a doctor removes a small amount of the infants blood and injects in its place the same amount of new blood. By doing this approximately twentyfive times with increments of 20 cc. of blood, the infants old blood is largely replaced.

Previously, doctors using disposable equipment performed this procedure with at least two valves connected together to direct fluid from an operating syringe selectively to (1) the infant, (2) 'a new blood source, (3) a drainage container, and (4) a source for adding additional medicament. Each valve had its separate handle and there was no logical and easy way to remember progressive sequence in the operation of these handles. Fatigue resulting from the several hours length of this operation made concentration on using exactly the right combination of valve settings a difiicult task. In the tricky exchange transfusion procedure, it was easy for the doctor to become confused and sometimes inject old blood back into the infant or feed new blood to the drainage container.

It is an object of this invention to provide a disposable exchange transfusion system which has a single valve.

Another object of this invention is to provide an exchange transfusion system which is easy and simple to operate. 7

Another object of this invention is to provide an exchange transfusion system which has a logical sequence of steps in its repetitive cycles so as to be essentially error-free.

Still another object of this invention is to provide a novel exchange transfusion valve which can be actuated by rotation of an attached syringe progressively in a particular direction.

Other objects of this invention will become apparent from a further description and from the following illustrations, in which:

FIGURE 1 is a perspective view partially cut away of the exchange transfusion system;

FIGURE 2 is a front elevational view of the exchange transfusion valve;

FIGURE 3 is a top plan View of the exchange transfusion valve;

FIGURE 4 is an enlarged sectional view of the exchange transfusion valve core;

3,344,785 Patented Oct. 3, 1967 FIGURE 5 is an enlarged sectional view of the lower end of the valve in FIGURE 2 showing the partially assembled valve;

FIGURE 6 is an enlarged sectional view of the lower end of the valve in FIGURE 2 showing the completely assembled valve; and

FIGURE 7 is a further enlarged fragmentary view partially in section of the exchange transfusion valve connected to a syringe tip.

As shown in FIGURE 1, the assembled exchange transfusion system has a syringe 10 that connects through a tip 11 to a core 3 rotatably mounted in a bore in body 2 of valve 1. Core locking means 13 in the form of outwardly extending flanges engages syringe tip locking means 12 and holds the syringe 10 from rotary movement relative to core 3. Thus, core 3 can be rotated in valve body 2 by holding valve body 2 and rotating syringe 10. Indicating means 14 on core 3 aligns with the particular tubular side arm 4a, 4b, or 40 which the valve core 3 connects to syringe 10. If indicating means 14 is not aligned with a particular tubular side arm, the valve port is closed off. When, for instance, indicating means 14 is positioned between two adjacent side arms, syringes can be interchangeably connected to and disconnected from the valve without disrupting the exchange transfusion setup.

Referring now to FIGURES 2, 3, and 4, the core 3 has a passage 17 that extends longitudinally therethrough. The core 3 also has a transverse port 18 for selectively connecting passage 17 with a particular tubular side arm 40, 4b, or 40. Retaining means 6 and stop means 9 engage body 2 and hold core 3 within the body bore. Adjacent the first end 15 of the core which extends beyond body 2 is an internal Luer taper for receiving a hollow male Luer adapter 22 (shown in FIGURE 7) of syringe tip 11 in fluid-tight relationship. In any position of the valve, additional medicament such as calcium gluconate can be injected (as illustrated by the dotted needle in FIGURE 1) through a pierceable, resealable diaphragm 7 closing off injection aperture 19 of retaining means 6. In addition to adding medicament, the interior of the valve can be rinsed and blood clots flushed out by injecting saline solution through diaphragm 7 without disconnecting the system. I

As shown in FIGURES 5 and 6, the core 3 adjacent its second end 16 has an internal annular recess 20 into which fits the pierceable, resealable diaphragm 7. This diaphragm is firmly held within this recess 20 by retaining means 6 which is axially press-fitted to core 3. This second end 16 of core 3 is one of the critical areas of the valve. If any liquid, such as blood, seeps around the puncturable resealable diaphragm 7, creep contamination can enter the valve and infect the infant.

In my invention, the pierceable, resealable diaphragm 7 is held so tightly under compression against the valve core 3 that creep contamination does not occur. Adjacent the second end 16 of core 3- is a thin skirt 25 which contacts retaining means 6. My method in making this valve includes the step of axially press-fitting the retaining means 6 to core 3 and applying heatand pressure so as to deform this thin skirt 25 and fuse it to retaining means 6. During the step of applying heat and pressure, such as in spin welding, retaining means 6 simultaneously advances upwardly and longitudinally along the core, thus firmly compressing the puncturable, resealable diaphragm 7 to core 3. The valve does not seep liquid past diaphragm 7 even when the core 3 with its attached retaining member 6 and diaphragm 7 are rotated relative to the body 2 by syringe 10.

The interrelationship between the syringe tip locking means 12 and the core locking means 13 is shown in FIG- URE 7. The syringe tip locking means 12 includes two separate spiral threads on a sleeve 26 of the syringe tip 11. Sleeve 26 surrounds and is spaced from a hollow adapter 22 of syringe tip 11, which adapter has an outer surface that tapers radially inwardly to an external end of the adapter. The core locking means 13 has a pair of flanges extending outwardly from opposite sides of the core 3. These flanges each have an undersurface 21 for engaging one of the syringe tip threads along at least a distance substantially equivalent to the diameter of core 3. The top View of the flanges 13 in FIGURE 3 shows the length of flanges 13. The large amount of surface engagement between core locking means 13 and syringe tip locking means 12 greatly reduces any chance for distortion of the syringe tip sleeve 26 and its spiral threads. If the core locking means has only narrow points of contact with the sleeve threads, a thermoplastic sleeve such as 26 is likely to distort into an egg-shape, thus losing its grip on the valve during the critical exchange transfusion. In my invention, I have been able to integrally mold the two spiral threads in thermoplastic sleeve 26 and strip them from an undercut section of a syringe mold without expensively unscrewing each individual syringe from a mold cavity. Despite the thinness of the threads stripped from the mold, my valve reliably and firmly holds to the syringe.

The procedure for using my invention can be understood by referring to FIGURE 1. A flexible umbilical catheter 8a is attached to tubular side arm 4a. Tube 8b is connected to the new blood source (not shown) and the tube 8c connected to the drainage container (not shown). The system is then filled with new blood and the umbilical catheter inserted into the infants umbilical vein. With indicating means 14 aligned with tubular side arm 4a, approximately 20 cc. of blood is withdrawn from the infant. Next, the doctor twists the syringe clockwise (as he faces it), rotating the valve core until indicating means 14 is aligned with tubular side arm 4b and empties the old blood in syringe 10 into the drainage container. With the empty syringe, the doctor turns the valve again clockwise until the indicating means 14 aligns with tubular side arm 41;. After filling the syringe with new blood the valve again is turned clockwise until indicating means 14 aligns with side arm 4a, i.e. the original position, and the. new blood injected into the infant. This procedure is repeated until a sufiicient amount of the infants old blood is replaced with new blood. This usually takes about twentyfive cycles.

It should be noted that this exchange transfusion system is extremely simple and convenient to operate because it has a simple logical sequence to the various steps in each cycle. The doctor can turn the valve core by turning the syringe and hence can actuate the valve with one hand by twisting the syringe while holding the valve with the other hand. He can operate a plunger of the syringe without changing the position of either hand. The doctor always knows where he is in a particular cycle because of indicating means 14 and because he is progressively turning the syringe in the same direction, such as clockwise.

Preferably, the exchange transfusion valve is made of a thermoplastic material such as Delrin, nylon, or polyethylene. Thus, the valve can be made inexpensively enough to be disposed of after a single exchange transfusion. Because of the difliculties of cleaning the valves completely and the dangers of cross infection, this is an important advantage.

I have used; specific examples to describe my invention for illustrative purposes. Certain modifications can be made to these specific examples by those skilled in the are without departing from the spirit and scope of this invention.

I claim:

1. A disposable medical valve comprising:

(a) a body with a bore therethrough;

(b) tubular side arms extending outwardly from the body and communicating with the body bore;

(0) a core rotatably mounted in said body bore and having a longitudinal passage extending between first and second ends of the core, said core having a portion adjacent its first end adapted to receive a syringe tip in fluid-tight engagement and having a port for selectively connecting the core passage with said tubular side arms upon rotary movement of said core relative to said body;

(d) locking means on said first end of said core for holding a syringe tip against rotary movement with respect to said core;

(e) a retaining member connected to the core adjacent its second end for slideably engaging the body to limit axial movement of said core in said body; and

(f) a pierceable, resealable diaphragm closing off an injection aperture in the retaining member, through which diaphragm medicaments can be added to the core passage.

2. A disposable medical valve as set forth in claim 1 wherein the core includes an internal recess at its second end in which the pierceable, resealable diaphragm is retained.

3. A disposable medical valve as set forth in claim 1 wherein the retaining member is axially press fitted to the second end of the core.

4. A disposable medical valve as set forth in claim 1 wherein the core has an annular internal recess in which the pierceable, resealable diaphragm fits and which is held therein by said retaining member, said recess being surrounded by a thin cylindrical deformed skirt fused to said retaining member.

5. An exchange transfusion system comprising:

(a) a syringe having a tip and locking means associated with this tip; and

(b) an exchange transfusion valve connected with the syringe tip, said exchange transfusion valve includmg (1) a body with a bore therethrough,

(2) tubular side arms extending outwardly from the body and communicating with the body bore,

(3) a core rotatably mounted in said body bore and having a longitudinal passage extending between a first open end and a second closed end of the core, said core having a tapered inner surface adjacent its first end which engages the syringe tip in a fluid-tight manner, which core has a port for selectively connecting the core passage with any of said tubular side arms upon rotary movement of said core relative to said body, and

(4) locking means on the core separate from the tapered inner surface of the core for engaging the syringe tip locking means and holding the syringe against rotary movement relative to the core whereby rotation of the syringe in turn rotates the valve so as to connect the core progressively with each tubular side arm during an exchange transfusion cycle.

6. An exchange transfusion system as set forth in claim 5 wherein the core is infinitely rotatable in at least one direction relative to the body.

7. An exchange transfusion system comprising:

(a) a syringe having a tip, which tip includes (1') a hollow adapter having an outer surface which tapers radially inwardly to an external end of the adapter, and

(2) a sleeve surrounding the, hollow adapter at a distance therefrom, said sleeve having syringe tip locking means thereon; and- ,(b) an exchange transfusion valve including (1) a body with a bore therethrough,

(2) tubular side arms extending'outwardly from the body and communicating with the body bore,

(3) a core rotatably mounted in said body bore and having a longitudinal passage extending between a first open end and a second closed end of the core, which core has a port therein for connecting the longitudinal passage to a tubular side arm, said core having an internal surface which tapers radially outwardly toward its first open end, said surface frictionally engaging the outer surface of the hollow adapter of the syringe tip in a fluid-tight manner, and

(4) locking means connected to the core adjacent its open end, said core locking means engaging the syringe tip locking means and holding the syringe from rotary movement relative to the core, whereby the core and syringe are rotatable relative to the body by rotary force applied to the syringe.

References Cited STATES PATENTS Wandel 128-214 Bierman 128-214 Pennington 128-214 Cowley 128-214 Harautuneian 137-62547 Buono 137-625.42 Jinkens et a1. 137-556 FOREIGN PATENTS UNITED France. Great Britain.

15 RICHARD A. GAUDET, Primary Examiner.

D. L. TRULUCK, Examiner. 

1. A DISPOSABLE MEDICAL VALVE COMPRISING: (A) A BODY WITH A BORE THERETHROUGH; (B) TUBULAR SIDE ARMS EXTENDING OUTWARDLY FROM THE BODY AND COMMUNICATING WITH THE BODY BORE; (C) A CORE ROTATABLY MOUNTED IN SAID BODY BORE AND HAVING A LONGITUDINAL PASSAGE EXTENDING BETWEEN FIRST AND SECOND ENDS OF THE CORE, SAID CORE HAVING A PORTION ADJACENT ITS FIRST END ADAPTED TO RECEIVE A SYRINGE TIP IN FLUID-TIGHT ENGAGEMENT AND HAVING A PORT FOR SELECTIVELY CONNECTING THE CORE PASSAGE WITH SAID TUBULAR SIDE ARMS UPON ROTARY MOVEMENT OF SAID CORE RELATIVE TO SAID BODY; (D) LOCKING MEANSA ON SAID FIRST END OF SAID CORE FOR HOLDING A SYRINGE TIP AGAINST ROTARY MOVEMENT WITH RESPECT TO SAID CORE; (E) A RETAINING MEMBER CONNECTED TO THE CORE ADJACENT ITS SECOND END FOR SLIDEABLY ENGAGING THE BODY TO 